Actively Recruiting
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Led by Massachusetts General Hospital · Updated on 2025-10-22
120
Participants Needed
1
Research Sites
659 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
CONDITIONS
Official Title
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A previous diagnosis of Barrett's Esophagus (for BE participants only)
- Participants 18 years and older with a previous diagnosis of GERD
- Participants 14 years and older with a previous diagnosis of EoE (for EoE participants only)
- Healthy participants aged 18 to less than 85 years
- Ability to give informed consent
- No solid food for 4 hours prior to the procedure and only clear liquids for 2 hours prior to the procedure
You will not qualify if you...
- Participants older than 85 years
- Inability to swallow pills and capsules
- Strong gag reflex
- Presence of esophageal fistula or strictures with diameter smaller than the capsule
- Pregnancy or uncertain pregnancy status (women of childbearing age may be asked to take a pregnancy test)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
J
Juleen Guoy, RN
CONTACT
A
Anita Chung, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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